NCT05936983

Brief Summary

According to the World Health Organization; Bipolar disorder ranks in the top 20 causes of disability among all medical conditions and 6th among mental disorders worldwide. Bipolar disorder is noted as a serious mental illness involving emotional ups and downs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 2, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

13 days

First QC Date

May 31, 2023

Last Update Submit

July 7, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Waist measurement - Antropometric Measurements

    Waist measurement is measured from the narrowest area between the subcostal region and the iliac crest.

    4 weeks

  • Abdomen measurement - Antropometric Measurements

    Abdomen measurement is measured at the level of the umbilicus without compression of the tissues.

    4 weeks

  • The hip measurement - Antropometric Measurements

    The hip measurement is measured from the thickest part of the hip area.

    4 weeks

  • Eurofit Test Battery

    A test-retest design was applied to test the reproducibility of several Eurofit test battery items. Supervision and measurement of the Eurofit test battery was performed by one trained mental health physical therapist following a standardized procedure. The Eurofit test battery included seven items and involved the assessment of the following measures: whole body balance, speed of limb movement, flexibility, explosive strength, static strength, abdominal muscular endurance and running speed.

    4 weeks

  • Quick Inventory of Depressive Symptomatology (QIDS-SR16) scale

    QIDS-SR consists of 16 items each ranging from 0 to 3. It is scored by summing the highest response in each of a set of questions relating to sleep, weight and psychomotor symptoms and then adding the remaining items

    4 weeks

  • International Physical Activity Questionnaire

    The IPAQ questionnaires list activities and request estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known METs per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. A sitting question is not included in physical activity score.

    4 weeks

Study Arms (3)

Patients with Bipolar disorder

Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively.

Patients with Schizophrenia group

Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively.

Healthy group

Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively.

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients with Bipolar disorder and schizophrenia come to the community mental health center regularly

You may qualify if:

  • Individuals diagnosed with bipolar disorder and schizophrenia by a physician according to DSM-5 criteria
  • Individuals with bipolar and schizophrenia between the ages of 30-55
  • Patients without any other accompanying psychiatric disorder
  • Patients who can communicate
  • Patients who agreed to participate in this study and gave informed consent

You may not qualify if:

  • Patients with a psychiatric diagnosis other than bipolar and schizophrenia.
  • Pregnancy condition
  • Those who did not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Ebru Akbuğa Koç

    Yeditepe University

    PRINCIPAL INVESTIGATOR
  • İsmail Koç

    Kartal Dr. Lütfi Kirdar City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 10, 2023

Study Start

June 2, 2023

Primary Completion

June 15, 2023

Study Completion

June 20, 2023

Last Updated

July 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations